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Completed

NCT Number: NCT05561439

Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France

The objective of this study is to review the results of annual radiation doses received by interventional cardiologists and radiologists in France. The results of this study will allow the improvement of classification of interventional cardiology and radiology activities and procedures to help define radiation dose constraints for occupational exposure, according to the number and types of procedures performed.

The study is based on the hypothesis that some specialties in interventional cardiology (cardiology or rythmology procedures) and in interventional radiology (vascular, neuroradiology, osteoarticular) and some types of procedures present greater exposure risks for interventional cardiologists and radiologists. It is expected that the annual radiation dose limits for workers can be exceeded if good practices for both patient and worker radiation protection are not applied. Also, dosimetry equipment used to detect radiation dose although provided to the workers are not systematically worn by the physician during the procedure . The study is likely to show that for an equivalent speciality and number of procedures per type of act, the correct use of collective and personal radiation protection equipment (préciser) will lower occupational radiation exposure of physician . Similarly, for an equivalent activity and number of procedures per type of act , a trained physician would have a lower occupational exposure than an untrained physician. The physician's radiation exposure should therefore increase with a greater number of procedures per type of procedure performed and as the radiation dose delivered to the patient increase. Finally, there would be a different correlation between patient's radiation dose and physician's exposure depending on specialty, procedures, modality, experience and availability and use of collective and personal radiation protection equipment.

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Key information

Conditions

Radiation Exposure

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician performing interventional cardiology or radiology procedures with a fixed C-arm system
  • Physician systematically wearing at least one of the following personal dosimeters: whole body, extremities, lens.

Exclusion criteria

  • Physician who did not perform an interventional procedure during the observation period (2019-2021)
  • For the primary endpoint by year, physician with more than 3 months of missing data (more than one 3-month period or more than 3 1-month periods)

Treatment and study plan

Dosimetric monitoring

Other

Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021

Primary outcomes

  1. Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2019

    mSv

  2. Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2020

    mSv

  3. Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2021

    mSv

  4. Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2019

    mSv

  5. Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2020

    mSv

  6. Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2021

    mSv

  7. Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2019

    mSv

  8. Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2020

    mSv

  9. Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed

    Time frame: 2021

    mSv

Secondary outcomes

  1. Availability and frequency of use for each passive dosimeter

    Time frame: 2019

    Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  2. Availability and frequency of use for each passive dosimeter

    Time frame: 2020

    Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  3. Availability and frequency of use for each passive dosimeter

    Time frame: 2021

    Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  4. High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  5. High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  6. High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  7. High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  8. High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  9. High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  10. Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  11. Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  12. Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  13. Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  14. Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  15. Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  16. Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  17. Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  18. Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  19. Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  20. Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  21. Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  22. Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  23. Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  24. Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  25. Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019,

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  26. Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  27. Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  28. Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019, 2020 and 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  29. Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  30. Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  31. Gloves use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  32. Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2019

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  33. Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2020

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  34. Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed

    Time frame: 2021

    Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed

  35. Patient radiation protection training status according to specialty, activity and type of procedures performed

    Time frame: 2019,

    Up-to-date/needs renewing/never completed

  36. Patient radiation protection training status according to specialty, activity and type of procedures performed

    Time frame: 2020

    Up-to-date/needs renewing/never completed

  37. Patient radiation protection training status according to specialty, activity and type of procedures performed

    Time frame: 2021

    Up-to-date/needs renewing/never completed

  38. Worker radiation protection training status according to specialty, activity and type of procedures performed

    Time frame: 2019

    Up-to-date/needs renewing/never completed

  39. Worker radiation protection training status according to specialty, activity and type of procedures performed

    Time frame: 2020

    Up-to-date/needs renewing/never completed

  40. Worker radiation protection training status according to specialty, activity and type of procedures performed

    Time frame: 2021

    Up-to-date/needs renewing/never completed

  41. Physician exposure according to total number of procedures

    Time frame: 2019

    mSv: Information taken from Dosimetry Archiving and Communication System

  42. Physician exposure according to total number of procedures

    Time frame: 2020

    mSv: Information taken from Dosimetry Archiving and Communication System

  43. Physician exposure according to total number of procedures

    Time frame: 2021

    mSv: Information taken from Dosimetry Archiving and Communication System

  44. Physician exposure according to number of procedures by type of specialty

    Time frame: 2019

    mSv: Information taken from Dosimetry Archiving and Communication System

  45. Physician exposure according to number of procedures by type of specialty

    Time frame: 2020

    mSv: Information taken from Dosimetry Archiving and Communication System

  46. Physician exposure according to number of procedures by type of specialty

    Time frame: 2021

    mSv: Information taken from Dosimetry Archiving and Communication System

  47. Physician exposure according to number of procedures by modality

    Time frame: 2219

    mSv: Information taken from Dosimetry Archiving and Communication System

  48. Physician exposure according to number of procedures by modality

    Time frame: 2020

    mSv: Information taken from Dosimetry Archiving and Communication System

  49. Physician exposure according to number of procedures by modality

    Time frame: 2021

    mSv: Information taken from Dosimetry Archiving and Communication System

  50. Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2019

    Gy.cm²

  51. Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2020

    Gy.cm²

  52. Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2021

    Gy.cm²

  53. Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2019

    mGy

  54. Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2020

    mGy

  55. Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2021

    mGy

  56. Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2019

    mGy.cm

  57. Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2020

    mGy.cm

  58. Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed

    Time frame: 2021

    mGy.cm

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists

Acronym: DOSE RPW-CRI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 30, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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